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FDA 510(k)

AMP ALKALINE PHOSPHATASE REAGENT KIT

K-Number: K931986 · 1993-09-08

ApplicantSynermed, Inc.
Decision Date1993-09-08
Product CodeCJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMP ALKALINE PHOSPHATASE REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Synermed, Inc.. It received FDA 510(k) clearance on 1993-09-08 under 510(k) number K931986. The device is classified under product code CJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMP ALKALINE PHOSPHATASE REAGENT KIT?

AMP ALKALINE PHOSPHATASE REAGENT KIT is a medical device that received FDA 510(k) clearance on 1993-09-08. The listed applicant is Synermed, Inc.. The 510(k) number is K931986.

When did AMP ALKALINE PHOSPHATASE REAGENT KIT receive FDA 510(k) clearance?

AMP ALKALINE PHOSPHATASE REAGENT KIT received FDA 510(k) clearance on 1993-09-08, under 510(k) number K931986.

Who is the listed applicant for AMP ALKALINE PHOSPHATASE REAGENT KIT?

The FDA 510(k) record lists Synermed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMP ALKALINE PHOSPHATASE REAGENT KIT?

The FDA product code for AMP ALKALINE PHOSPHATASE REAGENT KIT is CJE.

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Other records listing Synermed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK960793SYNERMED ENZYMATIC CO2 REAGENT KIT

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Related Devices (Code: CJE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251074Tru Liver Health Test PanelTruvian HealthK240468Alkaline PhosphataseAbbott Laboratories Diagnostics DivisionK223317Alkaline Phosphatase2Abbott Ireland Diagnostics DivisionK191245Yumizen C1200 ALP, Yumizen C1200 AlbuminHORIBA ABX SASK171971Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry AnalyzerLite-On Technology Corp. H.S.P.B.K171080ALP IFCC Gen.2Roche Diagnostics Operations (Rdo)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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